Approvals

EC launches probe into Aspen’s pricing practices for cancer drugs

The European Commission has initiated a formal investigation to see whether Aspen Pharma had excessively priced five life-saving cancer medicines.

Merck’s Keytruda in combination with chemotherapy gets FDA nod to treat NSCLC

Merck’s Keytruda (pembrolizumab) in combination with pemetrexed (Alimta) and carboplatin (pem/carbo) has been approved by the US Food and Drug Administration (FDA) for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression.

XyloCor’s cardiovascular gene therapy gets FDA fast track designation

The US Food and Drug Administration (FDA) has granted Fast Track designation to XyloCor Therapeutics’ lead product candidate XC001 (AdVEGF-All6A+), a cardiovascular angiogenic gene therapy.

FDA accepts to review Pfizer’s sNDA for XELJANZ to treat adult PsA patients

The US Food and Drug Administration (FDA) has accepted for review Pfizer's supplemental New Drug Application (sNDA) for XELJANZ (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of adult patients with active psoriatic arthritis (PsA).

AstraZeneca’s bladder cancer drug imfinzi gets accelerated approval from FDA

The US Food and Drug Administration (FDA) has granted accelerated approval to AstraZeneca’s Imfinzi (durvalumab) for previously treated patients with advanced bladder cancer.

Takeda’s Alunbrig granted accelerated approval for Metastatic NSCLC

Takeda Pharmaceutical’s Alunbrig (brigatinib) has secured accelerated approval from the US Food and Drug Administration (FDA) for the treatment of anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) in patients whose disease has progressed on or are intolerant to crizotinib.

FDA approves Novartis’ Rydapt for AML and rare blood disorders

Novartis’ Rydapt (midostaurin) has secured approval from the US Food and Drug Administration (FDA) in newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of systemic mastocytosis (SM).

uniQure’s gene therapy for severe hemophilia B gets PRIME designation in Europe

uniQure’s AMT-060 investigational gene therapy in patients with severe hemophilia B, has been granted PRIME designation by the European Medicines Agency (EMA).

EMA’s CHMP recommends approval for Kevzara for rheumatoid arthritis

The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sanofi and Regeneron Pharmaceuticals’ Kevzara (sarilumab) for treating adult patients with moderately to severely active rheumatoid arthritis after adopting a positive opinion for its for its marketing authorization.